NDC Code(s) : 24987-377-10, 24987-378-10, 24987-379-34, 24987-382-37, 24987-434-00, 24987-435-00, 24987-412-00, 24987-413-00
Packager : Covis Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-377
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-377-1010 in 1 TRAY
117 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-378
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-378-1010 in 1 TRAY
126 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-379
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS170 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-379-3410 in 1 TRAY
160 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-382
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-382-376 in 1 TRAY
1127 mL in 1 VIAL, PHARMACY BULK PACKAGE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-434
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS56 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-434-0025 in 1 TRAY
118 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-435
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS111 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-435-0010 in 1 TRAY
118 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050578 12/14/2012
FORTAZceftazidime sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-412
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE(UNII: IY9XDZ35W2)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-412-0024 in 1 CARTON
150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050634 04/15/2013
FORTAZceftazidime sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-413
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE(UNII: IY9XDZ35W2)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-413-0024 in 1 CARTON
150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050634 04/15/2013

PRINCIPAL DISPLAY PANEL

500 mg Vial500 mg Vial

NDC 24987-377-10

Fortaz®

(ceftazidime for injection)

500 mg

Equivalent to 500 mg of ceftazidime.

For IM or IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 59 mg of sodium carbonate. The sodium content is approximately 27 mg (1.2 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

100035
Rev. 5/12
10000000103509

LOT
EXP
10000000103509

PRINCIPAL DISPLAY PANEL

1 gram Vial1 gram Vial

NDC 24987-378-10

Fortaz®

(ceftazidime for injection)

1 g

Equivalent to 1 g of ceftazidime.

For IM or IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 118 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

Rev. 5/12

100037
10000000103726

LOT
EXP
10000000103726

PRINCIPAL DISPLAY PANEL

2 gram Vial2 gram Vial

NDC 24987-379-34

Fortaz®

(ceftazidime for injection)

2 g

Equivalent to 2 g of ceftazidime.

For IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. To prepare IV solution, add 10 mL of Sterile Water for Injection. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 236 mg of sodium carbonate. The sodium content is approximately 108 mg (4.7 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

100031
Rev. 5/12
10000000103587

LOT
EXP
10000000103587

PRINCIPAL DISPLAY PANEL

6 gram Pharmacy Bulk Package6 gram Pharmacy Bulk Package

NDC 24987-382-37

Fortaz®

(ceftazidime for injection)

6 g

Equivalent to 6 g of ceftazidime.

Pharmacy Bulk Package

Rx only

See package insert for Dosage and Administration.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution.

To prepare solution, add 26 mL of Sterile Water for Injection. Shake well to dissolve. The constituted solution occupies a volume of about 31.5 mL and contains approximately 1 g of ceftazidime activity per 5 mL.

After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Color changes do not affect potency. This vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq) per gram of ceftazidime.

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England

10000000103768
100039
Rev. 5/12

LOT
EXP

PRINCIPAL DISPLAY PANEL

1 gram TwistVial Vial1 gram TwistVialTM Vial

NDC 24987-434-00

Fortaz®

(ceftazidime for injection)

TwistVialTM

1 g

Equivalent to 1 g of ceftazidime.

For IV use.

Rx only

See prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency. This vial contains 118 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq).

Distributed by:
Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England
Rev. 4/12

100001

10000000103171

LOT

EXP

PRINCIPAL DISPLAY PANEL

2 gram TwistVial Vial2 gram TwistVialTM Vial

NDC 24987-435-00

Fortaz®

(ceftazidime for injection)

TwistVialTM

2 g

Equivalent to 2 g of ceftazidime.

For IV use.

Rx only

See prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency. This vial contains 236 mg of sodium carbonate. The sodium content is approximately 108 mg (4.7 mEq).

Distributed by:
Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England
Rev. 4/12

100004

10000000103176

LOT

EXP

PRINCIPAL DISPLAY PANEL

1 gram Single-Dose Container Label1 gram Single-Dose Container Label

Fortaz® (ceftazidime injection)

12 - 50 mL Single-Dose Containers ISO-osmotic

Do Not Store Above -20oC. Do Not Refreeze.

1 g

Covis Pharmaceuticals, Inc.
Cary, NC 27511

COVIS

NDC 24987-412-00
Code 2G3535

(01) 20324987412002

GALAXY Container

Each 50 mL contains: ceftazidime sodium equivalent to 1 g of ceftazidime with approx. 2.2 g of Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium hydroxide and may have been adjusted with hydrochloric acid. pH 5.0 to 7.5.

Dosage: Intravenously as directed by a physician. See prescribing information.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

Rx only

Sterile, Nonpyrogenic

Do not store above -20oC. Thaw at room temperature (25oC) or under refrigeration (5oC). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 3 days under refrigeration or 8 hours at room temperature. Do not refreeze.

Fortaz is a registered trademark of GlaxoSmithKline

GALAXY is a trademark of Baxter International Inc.

Distributed by Covis Pharmaceuticals, Inc., Cary, NC 27511

Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015 USA

PL 2040 Plastic

Made in England

100012

07-04-68-558

Rev. 5/12

PRINCIPAL DISPLAY PANEL

2 gram Single-Dose Container Label2 gram Single-Dose Container Label

Fortaz® (ceftazidime injection)

12 - 50 mL Single-Dose Containers ISO-osmotic

Do Not Store Above -20oC. Do Not Refreeze.

2 g

Covis Pharmaceuticals, Inc.
Cary, NC 27511

COVIS

NDC 24987-413-00
Code 2G3536

(01) 20324987413009

GALAXY Container

Each 50 mL contains: ceftazidime sodium equivalent to 2 g of ceftazidime with approx. 1.6 g of Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium hydroxide and may have been adjusted with hydrochloric acid. pH 5.0 to 7.5.

Dosage: Intravenously as directed by a physician. See prescribing information.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

Rx only

Sterile, Nonpyrogenic

Do not store above -20oC. Thaw at room temperature (25oC) or under refrigeration (5oC). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 3 days under refrigeration or 8 hours at room temperature. Do not refreeze.

Fortaz is a registered trademark of GlaxoSmithKline

GALAXY is a trademark of Baxter International Inc.

Distributed by Covis Pharmaceuticals, Inc., Cary, NC 27511

Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015 USA

PL 2040 Plastic

Made in England

100014

07-04-68-559

Rev. 5/12